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Certain information must be submitted to the TGA for prescription medicine applications to proceed to evaluation.
Before you lodge your application, make sure you read Mandatory requirements for an effective application
Key information for applicants
- PageSubmit data in eCTD formatThis information explains how to submit data in the electronic Common Technical Document (eCTD) format.
- PageSubmit data in NeeS formatThis information explains how to submit data in the Non eCTD electronic Submission (Nees) format.
Guidance and resources
- PageSchedule of fees and charges to applications submitted to the TGAFees and charges summary from 1 July 2022 are available
- GuidanceCTD Module 1Module 1 of the CTD describes the administrative information and prescribing information for Australia to support the registration of a prescription medicine under section 23 of the Therapeutic Goods Act 1989 and the variation of the details of an ARTG registration for a prescription medicine under section 9D of the Act.
- GuidanceSubmitting a Drug Master File (DMF)This page is for industry stakeholders (e.g. manufacturers of active pharmaceutical ingredients) who provide Drug Master Files (DMF) to the TGA
- FormsForms for prescription medicine sponsorsA list of TGA forms for prescription medicine sponsors.
More information
- Stability testing for prescription medicines
- Guidance 18: Impurities in drug substances and drug products
- Guidance 11: Drug Master Files and Certificates of Suitability of a Monograph of the European Pharmacopoeia for drug substances
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Bioavailability, bioequivalence and biowaiver data summary forms
Dossier requirements
- General dossier requirements
- Dossier documents matrix: Module 1
- Dossier documents matrix: Module 2-5
- Submission dossier checklist for prescription medicines
Common technical document
Electronic submissions
- Australian electronic submission basics
- Electronic submissions
- AU eCTD specification: Module 1 and regional information
- eCTD AU module 1 and regional information
- Automation of validation of eCTD and NeeS sequences
Orphan designations
Priority Determinations
Provisional determinations
Minor Variations (includes Cat 3, SAR, SRR, MEC, EOI Generics, 9D(2C) Notifications
Additional Trade Name Applications
Section 14 exemption requests
Topics